FDA.reportPublic FDA data

Mega Menses

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:53

Label at a glance#

ProductMega Menses
Active ingredientAPIS MELLIFERA, CAPSELLA BURSA-PASTORIS, GOLDENSEAL, ALETRIS FARINOSA ROOT, APOCYNUM CANNABINUM ROOT, CINCHONA OFFICINALIS BARK, CINNAMON, CONIUM MACULATUM FLOWERING TOP, CHAMAELIRIUM LUTEUM ROOT, LILIUM LANCIFOLIUM WHOLE FLOWERING, ACHILLEA MILLEFOLIUM, PHOSPHORUS, CLAVICEPS PURPUREA SCLEROTIUM, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, TRILLIUM ERECTUM ROOT
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as prolonged or heavy menses and pelvic pain.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up take 6 drops by mouth one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mellifica 6x, Hamamelis virginiana 6x, Hydrastis canadensis 6x, Aletris farinosa 15x, Apocynum cannabinum 15x, Cinchona officinalis 15x, Cinnamomum 15x, Conium maculatum 15x, Helonias dioica 15x, Lilium tigrinum 15x, Millefolium 15x, Phosphorus 15x, Secale cornutum 15x, Thlaspi bursa-pastoris 15x, Trillium pendulum 15x.

OTC - PURPOSE SECTION

Formulated for symptoms such prolonged or heavy menses and pelvic pain.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4786-1Mega Menses30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4786MEGA MENSES (APIS MELLIFICA, HAMAMELIS VIRGINIANA, HYDRASTIS CANADENSIS, ALETRIS FARINOSA, APOCYNUM CANNABINUM, CINCHONA OFFICINALIS, CINNAMOMUM, CONIUM MACULATUM, HELONIAS DIOICA, LILIUM TIGRINUM, MILLEFOLIUM, PHOSPHORUS, SECALE CORNUTUM, THLASPI BURSA-PASTORIS, TRILLIUM PENDULUM.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201205_9a646b7e-23dd-c2e5-e053-2995a90a66c1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-478655714-4786-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
APIS MELLIFERA7S82P3R43ZACTIB
CAPSELLA BURSA-PASTORISW0X9457M59ACTIB
GOLDENSEALZW3Z11D0JVACTIB
ALETRIS FARINOSA ROOTO021JGR97XACTIB
APOCYNUM CANNABINUM ROOT2F92409L9ZACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CINNAMON5S29HWU6QBACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
PHOSPHORUS27YLU75U4WACTIB
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
TRILLIUM ERECTUM ROOTAHW6F0T2X0ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mega MensesAPIS MELLIFICA, HAMAMELIS VIRGINIANA, HYDRASTIS CANADENSIS, ALETRIS FARINOSA, APOCYNUM CANNABINUM, CINCHONA OFFICINALIS, CINNAMOMUM, CONIUM MACULATUM, HELONIAS DIOICA, LILIUM TIGRINUM, MILLEFOLIUM, PHOSPHORUS, SECALE CORNUTUM, THLASPI BURSA-PASTORIS, TRILLIUM PENDULUM.Newton Laboratories, Inc.9a646b7e-23dd-c2e5-e053-2995a90a66c12020-12-04WarningsExact identifier
ndc (package): 55714-4786-1
ndc (product): 55714-4786
ndc11 (package): 55714478601
spl id: b5aae85f-4c52-e3b4-e053-2995a90adb9b
spl set id: 9a646b7e-23dd-c2e5-e053-2995a90a66c1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.